FDA Product

Allopurinol

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

Allopurinol

FDA Product Code

54868-0075

Regulatory Information

NDC Product Code

54868-0075

Application Number

NDA018832

Marketing Category

C73594

Effective Date

June 10, 2010

Territorial Authority

USA

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

2

Company Information

ManufacturerPhysicians Total Care, Inc.

DUNS Number

194123980

Active Ingredients

Quantity: 100 mg in 1 1

Code: 63CZ7GJN5I

Class Code: ACTIM

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

Active Moieties

ALLOPURINOL

Code: 63CZ7GJN5I

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